Evaluation of Salt Sensitivity in Young Adults

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Salt tablet

• Registration Number: NCT02588352
• Lead Sponsor: NYU Langone Health

Brief Summary

The current prospective cross-sectional pilot study is proposed to determine a set of characteristic factors associated with salt sensitivity in young adults by measuring blood pressure, serum aldosterone levels, urine analysis, arterial pulse wave velocity and central arterial pressure in response to short term increases in salt intake.

Detailed Description

Since salt sensitivity at an early age is associated with subsequent hypertension and an increase in mortality, intervention by lifestyle modification including the reduction of sodium intake could prevent subsequent increases in blood pressure and development of hypertension, cardiovascular disease and death. It would therefore be beneficial to have a simple method of identifying salt sensitive young adults so that risk factor modification can be achieved to prevent progression of the effects of hypertension on heart function.

This study is a longitudinal pilot study to identify characteristics of salt sensitive young adults so that this population of people can be identified early on and appropriate lifestyle modifications can be made to prevent the subsequent progression of hypertension and cardiovascular disease.

The study will be conducted at 2 visits separated by one week. At the first visit, eligible subjects will be asked to complete questionnaires regarding childhood and current sodium intake.Subjects will be asked about family history of hypertension and cardiovascular disease. Subjects will also undergo blood pressure measurement in both arm, and will provide a blood sample and spot urine sample. Subjects will then be asked to take salt pills 3 times a day for one week, and then return to the study center for a repeat of the above measurements.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Young adults age 21-30
• Able and willing to provide written informed consent

Read More

Exclusion Criteria

• Any cardiovascular or other chronic health problem
• Chronic medications besides oral contraceptive pills in women
• BMI>30kg/m2
• Blood pressure >140/90 mmHg
• Inability or unwillingness to adhere to study procedures

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Salt tablet	Open label administration of salt tablets for one week

Primary Outcome Measures

Name	Time	Method
Presence of salt sensitivity	Visit 1 (One Week)	Defined as an increase in mean arterial blood pressure greater than 5 mmHg

Secondary Outcome Measures

Name	Time	Method
Change in aldosterone level	Baseline to Visit 2 (One Week)	change in serum aldosterone level
Change in augmentation index (%)	Baseline to Visit 2 (One Week)	Change in augmentation index determined by radial artery tonometry

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States